CELL THERAPY CATAPULT LTD · Awarded contract

Awarded

Pharmacovigilance Management Services for Cell Therapy Clinical Trial by Diamond PV

Awarded 26 Jul 2015

View live tenders

Awarded26 Jul 2015

Value£47,000.00

SupplierDiamond PV

AgencyCELL THERAPY CATAPULT LTD

RegionUnited Kingdom

CategoryHealth & Medical

Ended 8y 7mo ago2y 8mo term

Awarded 26 July 2015Expired 30 Mar 2018

About

CELL THERAPY CATAPULT LTD awarded a contract to Diamond PV for pharmacovigilance management services to support a phase I/II clinical trial of a cell therapy product in patients with Acute Respiratory Distress Syndrome.

The services covered standard clinical trial safety tasks including SAE handling and reporting, production of safety management plans, narratives, safety alert letters, single case reporting, periodic/annual reporting, DSMB reporting, and conducting safety reviews.

A DSMB convened approximately four times to review interim, unblinded safety data, with the primary safety and efficacy analysis performed after the last subject in Cohort 3 completed the Day 28 visit.

The contract value was AUD 47,000.

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